Medical Device Testing and Validation Regulatory Compliance Training - Live Webinars, Recordings & CDs

This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

Analyzing processes to understand their operation and implementing improvement is a necessary element in any quality system, but is especially important in medical devices. One of the more important tools is linear regression. Using Excel, you can get the information you need for process improvement.

This webinar will provide the basic understanding of how to conduct a compliant and effective out-of-specification (OOS) result investigation which is critical in preventing product recalls, voluntary and involuntary plant shut down, and FDA 483 findings or warning letter. It will also provide a basic mainframe for the Quality Assurance unit in the final disposition of the affected finished product as well as provide guidance for the different types of OOS investigational systems.

Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk.

This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.

This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.

This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.

This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.

This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.

This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.

This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.

The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

This training program will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The program will also help in getting projects completed on time and within budget.

The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

In this Cleaning validation training we will discuss preparing the cleaning validation protocol. Important aspects such as how to set acceptance criteria and how to measure cleanliness will then be reviewed.

This ASTM E2500 training will review how these ASTM (American Society for Testing and Materials) and ICH (International Conference on Harmonization) approaches can simplify the qualification process. Regulatory groups have responded by providing guidance documents such as ICH Q9: “Quality Risk Management” which encourages a level of risk appropriate to safety and efficacy and provides a toolbox of risk management methods. ICH Q8: “Pharmaceutical Development” encourages the use of scientific methods to mitigate risk through concepts such as Design Space, Quality by Design (QbD), Process Analytical Technology (PAT) and Continuous Verification.